Early Detection of Infectious and Noninfectious Lung Diseases Following Allogeneic Hematopoietic Stem Cell Transplantation

Conditions

• Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Eligibility Criteria

Sex

ALL

Age

5 Years - 70 Years

Healthy Volunteers

Not accepted

Study Details

Background: Stem cell transplants (called hematopoietic stem cell transplantation, or HSCT) are used to treat various diseases. But when the cells for this procedure are donated by someone other than the person who receives the HSCT ( allogeneic HSCT ), the recipient has an increased risk of lung inflammation and scarring. This happens when their immune cells attack healthy lung cells. In this natural history study, researchers will look for the best ways to detect developing lung inflammations earlier after an HSCT. Objective: To see if certain tests can detect early signs of lung inflammation in people after HSCT. Eligibility: People aged 5 to 70 years who will have HSCT as part of another NIH study. Design: Participants will undergo these tests prior to their HSCT. These tests will then be repeated regularly for 2 years: Ultra-low dose computed tomography (CT) scans. Participants will lie on a table that slides through a machine; the machine uses X-rays to get pictures of the inside of the body. This type of scan uses less radiation than normal CT scans. Bronchoscopy with lavage: Participants will be sedated. A flexible tube will be inserted through the mouth and into the airways. Salt water will be squirted into the lung, then sucked out to collect cells and fluids from the lung. Another tube with a camera may be inserted into the airways to take pictures. Blood tests. Blood will be drawn every 2 to 4 weeks. Pulmonary function tests. Participants will breathe into a machine to test their lung function. They will see how far they can walk in 6 minutes.

Key Dates

Start date

Apr 8, 2024

Status verified

Apr 2026

Primary completion

Oct 1, 2026

Completion

Oct 1, 2029

Study Design

Enrollment

40 participants (estimated)

Arms

• Arm: allogeneic HSCT
  Up to 30 men or women, 18 - 70 years of age, who are being treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorder at the NIH Clinical CenterUp to 10 children 5 - 17 years of age who are being treated with allogeneic HSCT for a hematologic malignancies, blood, or immune system disorder at the NIH Clinical CenterNIH Clinical Center

Primary Outcome Measure

To use preemptive assessments with sequential chest imaging and BAL measures to provide earlier identification of lung injury due to infection or alloreactive lung syndromes associated with HSCT. [ Time Frame: 30 months ]

Central Contacts

• Gloria Y Pastor, R.N.
  (301) 402-3484
  [email protected]
• Anthony F Suffredini, M.D.
  (301) 496-9320
  [email protected]

Locations (1)

Find similar trials in Bethesda, MD